NCT05902000

Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion

Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion: A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Xueli Cai · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

1. To evaluate whether stent implantation on the ipsilateral extracranial segment, after intracranial thrombectomy successful recanalization compared with balloon angioplasty (eTICI≥2b\_50) for acute anterior circulation tandem lesions within 24h of onset, can improve neurological functional outcomes(mRS≤2). 2. To evaluate whether stent implantation on the ipsilateral extracranial segment, after intracranial thrombectomy successful recanalization compared with balloon angioplasty (eTICI≥2b\_50) for acute anterior circulation tandem lesions within 24h of onset, can increase the risk of symptomatic intracranial hemorrhage.

Detailed description

The study was a prospective, randomized, open-label, blinded end-point Clinical Trial. Subjects were randomized 1:1 according to inclusion and exclusion criteria into a trial group (acute phase extracranial vascular stent implantation group) and a control group (acute phase non-extracranial vascular stent implantation group). Randomization was performed for 90d and 180d for the follow-up to collect primary and secondary efficacy and safety indicators.

Conditions

• Thrombectomy
• Tandem Occlusion
• Stroke

Interventions

Type	Name	Description
DEVICE	Carotid Stenting	Emergent carotid stenting will be performed if the patient is randomized in the intervention arm. The order to treat (head first or neck first) the extracranial carotid artery lesion will be left to the interventionist discretion.
PROCEDURE	Thrombectomy	Intracranial thrombectomy is an endovascular procedure. In the experimental group, thrombectomy will be completed with extracranial carotid stenting.
DRUG	Dual antiplatelet treatment	Dual antiplatelet therapy is administered after 24 hours of imaging follow-up excluding intracranial hemorrhagic complications. Aspirin Enteric-coated Tablets (Bay Aspirin) 100mg once a night+Clopidogrel Sulfate Tablets (Plavix) 75mg once daily. If there is no contraindication, maintain for more than 1 month, then adjust the dosing regimen according to the guidelines.
DRUG	Intraoperative Drug Treatment	Tirofiban is used as an adjunct to endovascular therapy. The currently recommended dosing regimen is a combined intra-catheter arterial administration of a loading dose of 0.4 μg/(kg-min) for 30 min (total dose not to exceed 1 mg)， followed by intravenous pumping of 0.1μg/(kg-min) for 24-48h, and adjustment of dosing in conjunction with CT.

Timeline

• Start date: 2023-06-14
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2023-06-13
• Last updated: 2023-06-28

Locations

1 site across 1 country: China